Shiley 6LPCRecalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 60884522007134), received between May 9, 2016 and Feb 9, 2024 — classified as 13 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (18 reports).

23 other recalls cover devices cleared under the same FDA submission (K962173); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE CUFF OF THE TRACHEOSTOMY CANNULA DEFLATES AFTER FIVE MINUTES PLACING IT ON THE PATIENT AND INFLATING THE CUFF. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 18676404 ↗
• MalfunctionMay 19, 2023Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE CANNULA ADAPTER OR THE CONNECTOR ON THE TUBE HAD DIMENSIONAL ISSUE DURING PROCEDURE. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 16967702 ↗
• MalfunctionJun 1, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE INNER CANNULA HAD AN ISSUE. IT WAS INDICATED THE DECANNULATION WAS REQUIRED. THERE WAS NO PATIENT INJURY.

  Patient problems: Unintended Extubation

  MAUDE report 11913530 ↗
• MalfunctionJun 1, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE INNER CANNULA HAD AN ISSUE. IT WAS INDICATED THE DECANNULATION WAS REQUIRED. THERE WAS NO PATIENT INJURY.

  Patient problems: Unintended Extubation

  MAUDE report 11913388 ↗
• MalfunctionMay 4, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE CUFF DEFLATED ON ITS OWN AT NIGHT DURING USE. THE CANNULA HAS BEEN IN PLACE FOR 4 WEEKS. CANNULA CHANGE REQUIRED.

  Patient problems: Unintended Extubation

  MAUDE report 11771356 ↗
• MalfunctionApr 27, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, AFTER ABOUT A MONTH OF FITTING THE CANNULA, THE PATIENT REALIZED THAT AT NIGHT THE BALLOON HAD DEFLATED ON ITS OWN. THE PATIENT HEARD THE AIR WAS PASSING AT THE LEVEL OF THE TRACHEA. THE BALLOON WAS DEFLATED AND THE WHITE PLASTIC INSIDE LOOKED "PEELED OFF". PATIENT MUST HAVE RE-INFLATED IT 15 TIMES DURING THE NIGHT. PATIENT HAD AN EMERGENCY APPOINTMENT TO CHANGE THE CANNULA.

  Patient problems: Unintended Extubation

  MAUDE report 11731463 ↗
• MalfunctionApr 21, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, AFTER ABOUT A MONTH OF FITTING THE CANNULA, THE PATIENT REALIZED THAT AT NIGHT THE BALLOON HAD DEFLATED ON ITS OWN. THE PATIENT HEARD THE AIR WAS PASSING AT THE LEVEL OF THE TRACHEA. THE BALLOON WAS DEFLATED AND THE WHITE PLASTIC INSIDE LOOKED "PEELED OFF". PATIENT MUST HAVE RE-INFLATED IT 15 TIMES DURING THE NIGHT. PATIENT HAD AN EMERGENCY APPOINTMENT TO CHANGE THE CANNULA.

  Patient problems: Unintended Extubation

  MAUDE report 11700135 ↗
• MalfunctionFeb 15, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD CUFF INFLATION/DEFLATION ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11327279 ↗
• MalfunctionDec 23, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE INNER CANNULA WAS DIFFICULT TO INSERT IN OUTER CANNULA AND SEEMED TO BE NOT COMPATIBLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11061885 ↗
• MalfunctionNov 9, 2020Defective Component; Defective Component

  ACCORDING TO THE REPORTER, DURING USE, THE CUFF WAS REFILLING WITHOUT BEING ATTACHED, AND SOME LIQUID WAS GETTING IN. THE DEVICE INFLATED AT NIGHT WHILE THE PATIENT WAS ON VENT, AND DEFLATED AT NIGHT. OVER THE PAST FEW WEEKS THERE HAD BEEN AIR REPORTED IN THE CUFF EVEN AFTER THE DEVICE DEFLATED. IT WAS INDICATED THAT IT WAS GOING ON WITH THE PREVIOUS TUBE AND NOW WITH THIS ONE THAT HAD BEEN IN FOR 2 WEEKS. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: No Information

  MAUDE report 10813994 ↗
• InjuryAug 28, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING THE INSERTION OF THE DEVICE, THE USER NOTICED THAT THE CUFF WAS NOT INFLATING.

  Patient problems: Extubate

  MAUDE report 10464316 ↗
• MalfunctionAug 19, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE WOULD NOT LOCK ON TO INNER CANNULA USING TWIST LOCK. IT WAS FOUND THAT THE INNER CANNULA DOES NOT FIT. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10426584 ↗
• InjuryAug 6, 2020Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE PRODUCT HAD A PIERCED CUFF CAUSING IT TO LOOSE PRESSURE. THE PRODUCT WAS REPLACED.

  Patient problems: Extubate; Unintended Extubation

  MAUDE report 10375905 ↗
• MalfunctionJul 6, 2020Use of Device Problem; Fitting Problem; Use of Device Problem; Fitting Problem

  ACCORDING TO THE REPORTER, THE DEVICE'S LOCKING SYSTEM WOULD NOT WORK PROPERLY AND THEREFORE THE INNER CANNULA CANNOT BE FIXED AND BLOCKED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10236020 ↗
• InjuryDec 17, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE UNIT'S CUFF DID NOT STAY INFLATED. THE PATIENT HAD DESATURATION AND IT WAS NECESSARY THAT DECANNULATION AND PASSAGE OF A NEW DEVICE WAS DONE TO REACH THE PATIENT STABILITY.

  Patient problems: Extubate

  MAUDE report 9480613 ↗
• MalfunctionOct 6, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE LOCK BETWEEN THE INNER AND OUTER TUBE WAS TOO TIGHT TO BE TWISTED OUT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9160329 ↗
• MalfunctionOct 6, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE LOCK BETWEEN THE INNER AND OUTER TUBE WAS TOO TIGHT TO BE TWISTED OUT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9160328 ↗
• InjuryOct 4, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE UNIT DEVICE CUFF PRESSURE WENT DOWN MANY TIMES. IT WAS INDICATED THAT THEY CHANGED THE CANNULA MANY TIMES.

  Patient problems: Extubate

  MAUDE report 9156515 ↗
• InjuryOct 4, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE UNIT DEVICE CUFF PRESSURE WENT DOWN MANY TIMES. IT WAS INDICATED THAT THEY CHANGED THE CANNULA MANY TIMES.

  Patient problems: Extubate

  MAUDE report 9154561 ↗
• InjuryOct 4, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE UNIT DEVICE CUFF PRESSURE WENT DOWN MANY TIMES. IT WAS INDICATED THAT THEY CHANGED THE CANNULA MANY TIMES.

  Patient problems: Extubate

  MAUDE report 9154554 ↗
• MalfunctionAug 2, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD CUFF INFLATION/DEFLATION ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8855612 ↗
• InjuryJul 1, 2019Leak/Splash; Use of Device Problem; Leak/Splash; Use of Device Problem

  ACCORDING TO THE REPORTER, THE UNIT HAD CUFF INFLATION/DEFLATION ISSUE ON THE PILOT BALLOON. RECANNULATION WAS REQUIRED.

  Patient problems: Extubate

  MAUDE report 8751264 ↗
• MalfunctionMar 28, 2019Crack; Crack

  ACCORDING TO THE REPORTER, A SMALL PIECE COMES OFF FROM THE OUTER TUBE FLANGE OF THE DEVICE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8459497 ↗
• MalfunctionMar 2, 2019Leak/Splash; Leak/Splash

  ACCORDING TO THE REPORTER, THE DEVICE HAD CUFF INFLATION/DEFLATION ISSUE. THERE WAS PATIENT INVOLVEMENT WITH NO REPORTED PATIENT OUTCOME.

  Patient problems: No Information

  MAUDE report 8384450 ↗
• MalfunctionFeb 3, 2019Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THE DEVICE¿S CUFF WOULD NOT STAY INFLATED. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8300569 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K962173. One submission often covers many models, so check the product and lot details in each record.

• Z-2174-2012 · Jul 18, 2012 · Terminated
  Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, model numbers (Worldwide) 8LPC, 8FEN; (Outside U.S.) 8FENJ, 8FENJ-S, 8LPC-S, 8FEN-S. Product Usage: The product
• Z-1478-2010 · Apr 13, 2010 · Terminated
  Shiley Low Pressure Cuffed Tracheostomy Tube, 4 LPC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper
• Z-1465-2010 · Apr 13, 2010 · Terminated
  Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 10 DCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended
• Z-1477-2010 · Apr 13, 2010 · Terminated
  Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 8 FEN-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton,
• Z-1462-2010 · Apr 13, 2010 · Terminated
  Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 4 DCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended f
• Z-1491-2010 · Apr 13, 2010 · Terminated
  Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 10 LPC-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Inten
• Z-1488-2010 · Apr 13, 2010 · Terminated
  Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 4 LPC-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intend
• Z-1472-2010 · Apr 13, 2010 · Terminated
  Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube, 8 DFEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA
• Z-1480-2010 · Apr 13, 2010 · Terminated
  Shiley Low Pressure Cuffed Tracheostomy Tube, 8 LPC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper
• Z-1481-2010 · Apr 13, 2010 · Terminated
  Shiley Low Pressure Cuffed Tracheostomy Tube, 10 LPC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper
• Z-1490-2010 · Apr 13, 2010 · Terminated
  Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 8 LPC-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intend
• Z-1489-2010 · Apr 13, 2010 · Terminated
  Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 6 LPC-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intend
• Z-1463-2010 · Apr 13, 2010 · Terminated
  Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 6 DCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended f
• Z-1471-2010 · Apr 13, 2010 · Terminated
  Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube, 6 DFEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA
• Z-1464-2010 · Apr 13, 2010 · Terminated
  Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 8 DCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended f

…and 8 more.